http://www.proactiveinvestors.com/columns/scimitar-equity/2101/reneuron-renel-files-2-clinical-trial-applications-in-uk-2101.html
ReNeuron submitted 2 applications to UK regulatory authority to commence multi-site ischemic stroke P2 clinical trial to examine efficacy of ReN001 and ReN009 for Critical Limb Ischemia (CLI).
The
ReN001 ischemic stroke trial is designed to recruit from a well-defined
population of patients between 2 and 4 months after their stroke, which
they believe will be the optimum treatment window for the therapy.
The
ongoing PISCES study with ReN001 continues on plan following the
commencement of treatment of patients in the penultimate dose cohort
last month, there remain no cell-related serious adverse events reported
in any of the patients treated to date. The independent Data Safety
Monitoring Board for the study will shortly make its recommendation
regarding treatment of the remaining patients in the penultimate dose
cohort. In June of this year, interim data from the PISCES study from
the first 5 patients treated was presented by the Glasgow clinical team
at the 10th Annual Meeting of the International Society for Stem Cell
Research (ISSCR) in Yokohama, Japan. Reductions in neurological
impairment and spasticity were observed in all 5 patients compared with
their stable pre-treatment baseline performance and these improvements
were sustained in longer term follow-up.
RENE.L
also submitted application to UK regulatory authority to commence a P1
clinical trial of ReN009 stem cell therapy for critical limb ischemia
(CLI). These patients will be administered via straightforward
intramuscular injection of the cells.
The Bottom Line: But … it is a competitive trial and market arena … Athersys (ATHX) is
also pursuing a P2 clinical trial in ischemic stroke. ATHX believes its
MultiStem therapy can help limit the associated damage that occurs post
ischemic stroke by down-regulating the immune response that follows.
ATHX is now conducting a 140-patient trial with data expected in 2H13.
MultiStem is a drug-like stem cell product that is produced by obtaining
a special class of stem cells from healthy, consenting donors. These
cells express proteins and other factors involved in tissue repair and
immune system regulation and act through multiple mechanisms, such as
protecting damaged or injured cells, reducing inflammation and promoting
new blood vessel formation in areas of ischemic injury. Aastrom (ASTM)is
recruiting for its P3 CLI trial which is on-going and headed to
completion. This trial will assess the efficacy and safety of
ixmyelocel-T in CLI patients. REVIVE will be conducted in the United
States across 80 sites and is targeting an enrollment of just under 600
no-option CLI patients. REVIVE represents the largest randomized,
double-blind, placebo controlled, multicenter study ever conducted in
patients with CLI. Pluristem (PSTI) reported
CLI P1 results in 11/11 of 27 patients in Germany. The PLX-PAD cells
therapy failed in 4 of the 27 patients, giving a rate was 85.2% after 12
months for the PLX-PAD cells therapy. However, little has been heard
since … stated it was planning to conduct its P2/3 trials for CLI in the
2H11.
How to I sign my 49 year old boyfriend for the clinical trial? Above web site did not work. He has global aphasia from feb 26 stroke. Physically is fine.
ReplyDeleteYou'll have to look at the reneuron site directly.
DeleteGeneral enquiries: info@reneuron.com
10 Nugent Rd
Surrey Research Park
Guildford, Surrey
GU2 7AF
UK
Telephone: +44 (0)1483 302560
Fax: +44 (0)1483 534864